Phase III Trial of Adjuvant Chemo-radiotherapy After D2 Surgery of Gastric Cancer

Phase 3

• Conditions: Gastric Cancer
• Interventions: Drug: Chemotherapy; Radiation: Concurrent chemo-radiotherapy

• Registration Number: NCT03601988
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

The purpose of this study is to explore the efficacy of adjuvant radiotherapy for D2 resected gastric cancer

Detailed Description

The radiotherapy dose of 45Gy in 25 fractions as adjuvant treatment after D2 surgery for gastric cancer

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-15
• Study First Submitted QC: 2018-07-25
• Last Update Submitted: 2018-07-25
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Study Start: 2018-07-28
• Primary Completion: 2020-07-28
• Study Completion: 2022-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

1. Aged 18-75；
2. Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction；
3. ECOG 0-1；
4. Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
5. D2 and R0 resection;
6. Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery;
7. More than 15 lymph nodes;
8. Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.

Exclusion Criteria

1. Previous radiotherapy or chemotherapy；
2. Inadequate organ function;
3. Pregnant or lactating women or women of childbearing potential.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	Adjuvant chemotherapy group receive 8 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1,capecitabine 1000mg po, Bid, D1-14, Q21D)
Chemo-radiotherapy	Concurrent chemo-radiotherapy	Adjuvant chemo-radiotherapy group receive 6 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1, capecitabine 1000mg po, Bid, D1-14, Q21D) and concurrent chemo-radiotherapy (capecitabine 825mg po, Bid, d1-5, QW)

Primary Outcome Measures

Name	Time	Method
DFS	36 months	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcome Measures

Name	Time	Method
OS	36 months	From date of randomization until the date of first documented death from any cause, assessed up to 36 months

Trial Locations

Locations (1)

Tongji hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China